LARS - Low Anterior Resection SyndromeRaLARSNCT05577845
5-HT3 Receptor Antagonist (Ramosetron) vs Loperamide for the Treatment of Low Anterior Resection Syndrome(RALARS)
A study testing Ramosetron in people with LARS - Low Anterior Resection Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Safety \& Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- LARS - Low Anterior Resection Syndrome
- What is being tested?
- Ramosetron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Mar 2023to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mid and low rectal cancer (AV<15cm)
- stage II, III, preop long-course CCRT, then ileostomy repair
- about 1~12 months after operation (no stomy)
- about 1~6 months after ileostomy repair
- major LARS
Who cannot join
- recurred rectal cancer
- stage IV
- IBD
- uncontrolled preoperative fecal incontinence or constipation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongro-gu, 03080
Seung-Bum Ryoo, MD, PhD, +82-2-2072-7294, sbryoomd@gmail.com
About this study
Official title: Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) Versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial
Safety \& Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial
- Conditions
- LARS - Low Anterior Resection Syndrome
- Being tested
- Ramosetron
- Medical subject headings
- Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RamosetronDrug
Ramosetron, 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Ramosetron | Experimental | Not described Receives: Drug: Ramosetron |
| Loperamide | Active comparator | Not described Receives: Drug: Ramosetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
major Low Anterior Resection Syndrome (LARS)
LARS score (0-20, no, 21-29, minor, 30-42, major)
Measured: 0 weeks
Difference of improvement of major Low Anterior Resection Syndrome (LARS)
LARS score (0-20, no, 21-29, minor, 30-42, major)
Measured: 4 weeks
Secondary outcomes (2)
EORTC QLQ-C30 score
Quality of life surveillance
Measured: 0 weeks
EORTC QLQ-C30 score
Quality of life surveillance
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start27 Mar 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LARS - Low Anterior Resection SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 212 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryoo, Seung-Bum, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577845
- Sponsor's protocol ID
- 2208-086-1351
- Acronym
- RaLARS
- Status last verified
- Apr 2023
- First submitted
- 28 Sep 2022
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety & Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) Versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05577845
- Acronym / sponsor ID
- RaLARS / 2208-086-1351
- Conditions
- LARS - Low Anterior Resection Syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 212 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Mar 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 13 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety \& Efficacy of 5-HT3 Receptor Antagonist (Ramosetron) versus Loperamide for the Treatment of Low Anterior Resection Syndrome (RALLARS): Multicenter Randomized Controlled Trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ramosetron | Experimental | Drug: Ramosetron |
| Loperamide | Active comparator | Drug: Ramosetron |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- mid and low rectal cancer (AV<15cm)
- stage II, III, preop long-course CCRT, then ileostomy repair
- about 1~12 months after operation (no stomy)
- about 1~6 months after ileostomy repair
- major LARS
Key exclusion criteria (4 listed)
- recurred rectal cancer
- stage IV
- IBD
- uncontrolled preoperative fecal incontinence or constipation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RamosetronRamosetron, 4 weeks | Drug | Loperamide, Ramosetron |
Primary outcome
major Low Anterior Resection Syndrome (LARS)
Time frame: 0 weeks
LARS score (0-20, no, 21-29, minor, 30-42, major)
Difference of improvement of major Low Anterior Resection Syndrome (LARS)
Time frame: 4 weeks
LARS score (0-20, no, 21-29, minor, 30-42, major)
2 secondary outcomes
EORTC QLQ-C30 score
Time frame: 0 weeks
EORTC QLQ-C30 score
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ramosetron in people with LARS - Low Anterior Resection Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major Low Anterior Resection Syndrome (LARS) (time frame: 0 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2023.